Country: United States
Language: English
Source: NLM (National Library of Medicine)
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)
Gland Pharma Limited
INTRAMUSCULAR
PRESCRIPTION DRUG
Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions: - Addisonian (pernicious) anemia - Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy - Fish tapeworm infestation - Malignancy of pancreas or bowel - Folic acid deficiency It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug Interactions ), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of cyanocobalamin. Requirements of vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral
Cyanocobalamin Injection, USP 1,000 mcg/mL NDC 68083-449-01 1 mL Fill in a 2 mL Multiple-Dose Vial NDC 68083-449-25 25 vials in a carton NDC 68083-561-01 10 mL Fill in a 10 mL Multiple-Dose Vial NDC 68083-561-25 25 vials in a carton NDC 68083-562-01 30 mL Fill in a 30 mL Multiple-Dose Vial NDC 68083-562-01 1 vial in a carton Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. PROTECT THE PRODUCT FROM LIGHT. Manufactured by: Gland Pharma Limited Hyderabad, India Revised: November 2022
Abbreviated New Drug Application
CYANOCOBALAMIN - CYANOCOBALAMIN INJECTION CYANOCOBALAMIN - CYANOCOBALAMIN INJECTION GLAND PHARMA LIMITED ---------- CYANOCOBALAMIN INJECTION, USP RX ONLY DESCRIPTION Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous injection. Each mL contains 1,000 mcg cyanocobalamin. Each vial also contains Sodium Chloride, 0.9%. Benzyl Alcohol, 1.5%, is present as a preservative. Hydrochloric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH (range 4.5-7.0). Cyanocobalamin appears as dark red crystals or as an amorphous or crystalline red powder. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). It is stable to autoclaving for short periods at 121°C. The vitamin B coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C H CoN O P. The cobalt content is 4.34%. The molecular weight is 1355.39. The structural formula is represented below. CLINICAL PHARMACOLOGY Vitamin B is essential to growth, cell reproduction, hematopoiesis, and nucleoprotein 12 63 88 14 14 12 and myelin synthesis. Cyanocobalamin is quantitatively and rapidly absorbed from intramuscular and subcutaneous sites of injection; the plasma level of the compound reaches its peak within 1 hour after intramuscular injection. Absorbed vitamin B is transported via specific B binding proteins, transcobalamin I and II to the various tissues. The liver is the main organ for vitamin B storage. Within 48 hours after injection of 100 or 1,000 mcg of vitamin B , 50 to 98% of the injected dose may appear in the urine. The major portion is excreted within the first eight hours. Intravenous administration results in even more rapid excretion with little opportunity for liver storage. Gastrointestinal absorption of vitamin B depends on the presence of sufficient intrinsic factor and calcium ions. Intrinsic factor deficiency causes pernicious anemia, which may be associated with subacute co Read the complete document